NEW YORK ─ Binx Health announced on Tuesday that Health Canada has issued a Medical Device Establishment License that enables the firm to distribute its at-home COVID-19 nasal swab sample collection kit in Canada.
Separately, North Carolina and Maryland have awarded contracts for the supply of Binx's at-home sample collection kits for SARS-CoV-2 molecular diagnostic testing using lower nasal swabs or saliva, the firm said Tuesday.
The awards, for an undisclosed amount, were granted by Maryland Office of State Procurement and the Division of Purchase & Contract in North Carolina to support the states' SARS-CoV-2 testing programs.
The North Carolina Statewide Term Contract mandates participation of agencies, departments, institutions, universities, and community colleges, unless exempted by North Carolina General Statute. Non-mandated entities including schools and local government that are allowed by general statute may use the COVID-19 testing contract.
As part of the North Carolina award, Binx Health will work with its partner laboratories and through an established in-network relationship with the North Carolina Blue Cross Blue Shield State Health Plan to reimburse for the laboratory fees associated with COVID-19 testing.
Last May, Binx obtained US Food and Drug Administration Emergency Use Authorization for its at-home COVID-19 swab sample collection kit, enabling individuals to provide samples in the home, school, work, and community settings.
In the US, samples are sent for processing to a Binx-authorized laboratory and, on average, results are available within 24 hours from when the lab receives a sample, the firm said.